House approves the 21st Century Cures Act, sending landmark bill to Senate

WASHINGTON — After three years of debate, countless hearings, and pleas from patient advocates, lawmakers on Tuesday approved legislation to speed new medicines to market and to authorize an additional $4.8 billion in spending for medical research.

The House of Representatives passed the 21st Century Cures Act by a 392 to 26 vote, showing a bipartisan spirit that has been rare in recent years. The Cures Act now heads to the Senate, for a vote early next week.

Supporters in Congress and patient advocacy groups said they were thrilled by the bill’s passage.

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“We are on the cusp of something special — a once-in-a-generation opportunity to transform how we treat disease,” said Representative Fred Upton (R-Mich.), who marshaled the legislation through the House. “With today’s vote, we are taking a giant leap on the path to cures.”

The Cures Act includes numerous provisions that set the stage for the faster approval of prescription drugs and medical devices. Although proponents claim these new measures will not lower safety standards, numerous critics, including some former Food and Drug Administration officials and national consumer groups, disagree. They have argued that FDA already moves faster than similar agencies in other countries.

The landmark legislation provides $4.8 billion for the three signature Obama administration research programs over the next 10 years: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative. It would also give states $1 billion to fight the opioid crisis, and deliver an additional $500 million to the FDA.

The bill heads to the Senate for a vote early next week. Senator Harry Reid (D-Nev.), the minority leader, acknowledged that there had been “angst” over the legislation among his colleagues, and several, including Senators Elizabeth Warren (D-Mass.) and Dick Durbin (D-Ill.), have said they will oppose it.

But party leaders on both sides of the aisle said they expect the bill to pass the Senate.

To lawmakers, that promise of extra funds — and the prospect of having to justify a vote against cancer research and efforts to fight opioid addiction — has trumped any other objections to the bill. Even critics acknowledged the bill included welcome measures.

Representative Tim Murphy (R-Penn.), who voted for the bill, was a driving force behind provisions that will fund mental health care programs.

“To all the families who brought their stories out of the shadows, that dared to share their sorrows, their hopes, their shattered dreams, today is a day of joy,” said Murphy, who is a psychologist.”And today is only possible, I say to all those families, because they dared to step forward.”

Critics had a host of concerns. Representative Rosa DeLauro (D-Conn.) said the bill would weaken regulations on medical devices, allow drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rush the use of new and unproven antibiotics.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said he was especially concerned about Cures Act provisions that will allow the FDA to consider “real world evidence” when approving drugs and allow companies to submit summaries of study data, rather than full clinical trial records.

“The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data,” Carome said. “I’m disappointed to see it. ’’

This was the second time that the House approved the Cures Act, which the chamber initially passed by an overwhelming margin in July 2015. Since then, it has been a long slog.

In the Senate, lawmakers split down party lines. Democrats would not approve the accelerated approval provisions unless funding for the National Institutes of Health and the FDA was included. For their part, Republicans said they would not support mandatory funding without figuring out how to pay for it.

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House and Senate leaders last Friday unveiled a new, compromise version of the Cures Act, which funds the research in part by selling off some of the Strategic Petroleum Reserve and in part by drawing down on funding for prevention programs in the Affordable Care Act.

Many consumer and patient advocacy groups were disappointed the legislation didn’t include more money for the NIH, and were critical of the way in which lawmakers have chosen to pay for it.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said he opposed the plan to divert funds by cutting the Prevention and Public Health Fund, by 30 percent, over the next seven fiscal years.

“The proposed cuts to the prevention fund would take away critical resources that could be used for programs to prevent kids from smoking and help smokers quit,” Myers said.

Mary Woolley, president and CEO of Research!America, agreed.

“We are disappointed that policymakers chose to redirect future increases in the Prevention and Public Health Fund to help offset the cost of this legislation, since that fund is a strategic investment in its own right,” she said. “Nonetheless, we believe this bill richly deserves the bipartisan support it enjoys, and we urge the Senate to pass and the president to sign it.”

The Cures Act initially included a rollback of requirements for companies to report certain payments to doctors. That provision was deleted Tuesday, after protest by Republican Senator Charles Grassley of Iowa.

It IS a giant ruse. It’s actually a total violation of the Nuremberg laws that require subjects of scientific experiments to give informed consent. Buried in that law are lines that allow you to be given experimental drugs and have experimental medical devices used without your knowledge or consent.

This is terrible news. While big corporations must be thrilled, the rest of us should be very scared. We are racing to the finish line, but we don’t seem to realize that awaiting us is the end of freedom of choice, informed consent, critical thinking and common sense solutions. The Nuremberg Code was created for a very particular reason – part of our “Never Again” promise. Imagine the repercussions of dismissing those principles.

More money for the pharmaceutical companies who probably “contributed” lots of dollars to get this bill passed. As long as they and their stockholders are “making” the tremendous amount of money they get, I seriously doubt that their will ever be a cure for anything. They should never, ever be in the stock market. Making money from sick people and keeping them sick is insane so they can make huge profits is totally insane!! This is another disgusting democrat bill

During the 5 years I ran Kern Hep and followed the research and experiments for treatment for HCV, I saw the risk of treatment related heart issues raise from 1% to 5%. Unfortunately for me, that risk rate hit my family and caused my husband to take an early heart-related disability retirement from his health care job after treatment. This job exposed him to this virus. I believed that the Pharms were not acting in good faith with regard to patient care. I am proud that a 97% cure has been uncovered in less than 30 years from the isolation of the virus to the current treatment. But this interim treatment was premature. There was a 17% clear rate of part of the specific strains and yet a 5% risk of heart issues. The trade off was not worth the risk of clearing a slow moving virus that allowed time for a more thorough research. It bothers me that this Cures bill was held up until the big Pharms got their desired goal of speeding up what has already shown to be an insufficient oversight on their research. A summary is insufficient and I am appalled that this is passing. It also bothers me that a wide-spread still unknown cause for Chronic Fatigue, a debilitating poverty-causing unknown illness impacting a huge percentage of the public, is not a major benefactor in this bill.

A medical “device” has ruined my retirement years, my marriage and health. Because of a shot in one knee both my legs and feet were impacted. I have bad balance and mobility issues. I can no longer be active dancing, tennis, walking, etc. I was very physical in my life. I could lose my legs long term. I could not sue since the Pharma corporations are too rich. No lawyer will go after them without a class action suit. I am left disabled without money to care and help me. I have been denied my Tort Rights in a court of law. The “device” was not even approved by the FCA yet. My doctor lied about the safety using me as a guinea pig? If I got bit on the face by a dog or was in an auto accident I could sue. Not a Pharma and doctor apparently.